Registration Dossier
Registration Dossier
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EC number: 700-591-1 | CAS number: 82203-23-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2007-08-08 - 2008-04-03
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- EC Number:
- 700-591-1
- Cas Number:
- 82203-23-4
- Molecular formula:
- C20H20Cl2O6
- IUPAC Name:
- (1R)-1-[(4R,4aR,8aS)-2,6-bis(4-chlorophenyl)-hexahydro-[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol
- Details on test material:
- - Name of test material (as cited in study report): DCBS
- Substance type: organic
- Physical state: white powder
- Analytical purity: no data
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA97, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9, two concentrations (5% and 10%)
- Test concentrations with justification for top dose:
- 0.05mg/plate, 0.15mg/plate, 0.5mg/plate, 1.5mg/plate, 5mg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: According to the physical and chemical state of the test substance and the result of preliminary test, DMSO was selected to be solvent of this test
Controls
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous revertant
- Negative solvent / vehicle controls:
- yes
- Remarks:
- 100µL bacteria solution + 0.5mL PBS + 100µl DMSO/100µL bacteria solution + 0.5mL S9-mix + 100µl DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191, P-NQ, MMS, NaN3, 2-AF, Danthron, and 2-AA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: AMES, direct plate incorporation
DURATION
- Preincubation period: not applicable
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: 160
NUMBER OF CELLS EVALUATED: 160
DETERMINATION OF CYTOTOXICITY
- Method: Number changes of revertant bacteria colony
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA97, TA98, TA100, TA102 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The number of revertant colonies of 5 dosages (0.05mg/plate~5mg/plate) of DCBS with and without S9-mix (two concentrations) had no significant difference to solvent control.
- Remarks on result:
- other: all strains/cell types tested
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
No toxic effect of the test item was observed in the experimental conditions, therefore, the test item is considered to be non-mutagenic.
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